The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1314-2015·Announced 2015-08-12

Apothecary Shoppe Recalls Phentolamine Vials Due to Sterility Concerns

The Apothecary Shoppe LLC is recalling SIU-Phentolamine 5 mg/mL vials in Oklahoma due to lack of documentation for environmental monitoring during production.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a documentation error regarding environmental monitoring. As no illnesses or injuries are reported and the hazard is a theoretical risk of contamination rather than a confirmed high-risk pathogen or structural defect, it falls under the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Phentolamine 5 mg/mL in Normal Saline, 10 mL vials. The recall is limited to Lot # 03102015@42 with a beyond-use date of 09/06/2015. The product was distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. Specifically, there was a lack of documentation confirming proper environmental monitoring during the time the medication was produced. This documentation gap raises concerns about the sterility of the compounded medication.

Consumers and healthcare providers who have this specific lot of SIU-Phentolamine should stop using it and contact The Apothecary Shoppe LLC or their healthcare provider for instructions on disposal or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — Compounded Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 03102015@42
  • BUD 09/06/2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 28 recalled by The Apothecary Shoppe LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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